Quality Control by Photo Documentation for Evaluation of Laparoscopic and Open Colectomy with D3 Resection for Stage II/III Colorectal Cancer: Japan Clinical Oncology Group Study JCOG 0404

Hostiuc

et al. 2017

WJGO

AIMTo compare the effectiveness of laparoscopic complete mesocolic excision (CME) with central vascular ligation (L-CME) with its open (O-CME) counterpart.METHODSWe conducted an electronic search of the PubMed/MEDLINE, Excerpta Medica Database, Web of Science Core Collection, Cochrane Center Register of Controlled Trails, Cochrane Database of Systematic Reviews, SciELO, and Korean Journal databases from their inception until May 2017. We considered randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that included patients with colonic cancer comparing L-CME and O-CME. Primary outcomes included the quality of the resected specimen (lymph nodes retrieved, complete mesocolic plane excision, tumor to arterial high tie, resected mesocolon surface). Secondary outcomes included the three-year and five-year overall and disease-free survival rates, recurrence of the disease, surgical data, and postoperative morbidity and mortality. Two authors of the review screened the methodological quality of the eligible trials and independently extracted data from individual studies.RESULTSA total of one RCT and eleven CCTs (four from Europe and seven from Asia) met the inclusion criteria for the current meta-analysis. These studies involved 1619 patients in L-CME and 1477 patients in O-CME. The L-CME was associated with the same quality of the resected specimen, with no differences regarding the retrieved lymphnodes (MD = -1.06, 95%CI: -3.65 to 1.53, P = 0.42), and tumor to high tie distance (MD = 14.26 cm, 95%CI: -4.30 to 32.82, P = 0.13); the surface of the resected mesocolon was higher in the L-CME group (MD = 11.75 cm2, 95%CI: 9.50 to 13.99, P < 0.001). The L-CME was associated with a lower rate of blood transfusions (OR = 0.45, 95%CI: 0.27 to 0.75, P = 0.002), faster recovery of gastrointestinal function, and less postoperative overall complication rate. The L-CME approach was associated with a statistical significant better three-year overall (OR = 2.02, 95%CI: 1.31 to 3.12, P = 0.001, I2 = 28%) and disease-free (OR = 1.45, 95% CI: 1.00 to 2.10, P = 0.05, I2 = 0%) survival.CONCLUSIONThe laparoscopic approach offers the same quality of the resected specimen as the open approach in complete mesocolic excision with central vascular ligation for colon cancer. The laparoscopic complete mesocolic excision with central vascular ligation is superior in all perioperative results and at least non-inferior in long-term oncological outcomes.

Section: Resultsmentioning

confidence: 99%

Laparoscopic vs open complete mesocolic excision with central vascular ligation for colon cancer: A systematic review and meta-analysis

Hostiuc

et al. 2017

WJGO

Annals of Gastroent Surgery

“…For quality control, the trial ensured that the surgeries were carried out by accredited surgeons, and a central review of each surgery was done on the basis of photographs obtained during the procedure. For the JCOG0404 trial, Nakajima et al reported that for right‐sided tumors, the proportion of D3 dissections was 98.5% (131/133) in OP and 100% (136/136) in LAP, and for left‐sided tumors, the proportion was 97.9% (322/329) in OP and 98.2% (320/326) in LAP, as evaluated by central review . Because quality of surgery is one of the important factors of surgery‐related adverse events, in terms of the proportion of D3 dissections carried out by accredited surgeons, the quality of surgery in the present study was high.…”

Section: Discussionmentioning

confidence: 99%

Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404)

Nishizawa

Akagi

Ito

et al. 2019

Objective To determine risk factors for early postoperative complications after D3 dissection for stage II/III colon cancer. Background Identification of risk factors for postoperative complications is essential in patients surgically treated for colon cancer. The Japan Clinical Oncology Group (JCOG) conducted a randomized controlled trial, JCOG0404, to confirm the non‐inferiority of laparoscopic surgery (LAP) to open surgery (OP) with D3 dissection for stage II/III colon cancer. This supplementary analysis was made to assess risk factors for surgery requiring D3 dissection using data from JCOG0404. Methods Proportion of postoperative complications of any grade (CTCAE ver. 3.0) until first discharge and risk factors for the most frequent complications were analyzed by univariable and multivariable analysis. Results Among 1057 randomized patients treated between October 2004 and March 2009, 520 patients with OP and 525 patients with LAP were analyzed. Overall postoperative complications of all grades occurred in 190 patients (18.2%). Multivariable analysis showed that the risk factors for overall early postoperative complications were OP itself (odds ratio [OR] 2.01, 95% confidence interval [CI]: 1.38‐2.91, P = 0.0003) and operation time of >240 minutes (OR 1.94, 95% CI: 1.24‐3.02, P = 0.0036). The most frequent adverse event was wound complication (50/1045, 4.8%). In the univariable analysis, reconstruction, greater blood loss, OP, and higher body mass index were significantly associated with wound complication. Conclusion Open surgery and longer operation time of >240 minutes were significant risk factors for postoperative complications. LAP surgery and shorter operation time could contribute to fewer postoperative complications in patients undergoing colectomy with D3 dissection. (Japan Clinical Oncology Group study JCOG 0404: NCT00147134/UMIN‐CTR: C000000105.)

Annals of Gastroent Surgery

“…After 2008, an endoscopically surgically qualified surgeon according to JSES was added as an indispensable board member. Submission of photographs of the resected field after D3 lymph node dissection, the specimen, and the skin incision in all patients was required for central review of the surgical procedure . Primary endpoint was overall survival.…”

Section: Methodsmentioning

confidence: 99%

Transitional impact of short‐ and long‐term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404

Fujii

Akagi

Ito

et al. 2019

Background The JCOG0404 randomized controlled trial conducted to compare laparoscopic surgery (LAP) with open surgery (OP) for stage II/III colon cancer showed better short‐term outcomes and equal long‐term outcomes of LAP versus OP. Technical instrumentation of surgery and anticancer agents given during the registration period might have affected the outcomes. Aim To evaluate outcomes according to the registration periods. Methods The overall registration period was divided into three periods (first: 2004‐2005, second: 2006‐2007 and third: 2008‐2009). Short‐term and long‐term outcomes were compared between registration periods. Results In total, 1057 patients were registered. Numbers of patients undergoing each approach for each of the three periods (1st/2nd/3rd) were 528 for OP (106/244/178) and 529 for LAP (106/246/177). Operation time (minutes) did not change between the periods for OP (160/156/161) or LAP (205/211/219). Blood loss (mL) gradually decreased in the latter two periods: (119/80/75) for OP and (35/28/25) for LAP. Incidence of complications (%) decreased in the latter periods for OP (27.6/20.3/21.3), whereas that for LAP remained consistently low (14.3/14.8/13.6). There was no particular trend in 5‐year overall survival and recurrence‐free survival depending on the period regardless of treatment. D3 dissection rates were 95% or more for all periods in both groups. Conclusions Operation time and survival rates did not change over time, whereas blood loss in OP improved in the latter periods. Quality control applied in this trial might have been effective in producing such safe endpoints. (ClinicalTrials.gov, number NCT00147134, UMIN Clinical Trials Registry, number C000000105.)